Table 1

Randomised controlled trials (RCT) of head-to-head biological DMARDs (bDMARD) and bDMARD RCTs including biosimilar and targeted synthetic DMARDs—American College of Rheumatology (ACR) responses

Biological DMARDTrial (reference)Treatment groupPatients evaluated (n)Time-point evaluated (months)ACR20 (%)p ValueACR50 (%)p ValueACR70 (%)p Value
A. Head-to-head bDMARDWeinblatt 2013 (AMPLE)15ABT 125 mg weekly+MTX3181264.8Referent46.2Referent29.2Referent
ADA 40 mg every 2 weeks+MTX32863.4NS46.0NS26.2NS
Gabay 2013 (ADACTA)51ADA 40 mg every 2 weeks162649.4Referent27.8Referent17.9Referent
TCZ 8 mg/kg every 4 weeks16365.00.003847.20.000232.50.0023
B. Biosimilar DMARDYoo ARD 2013 (PLANETRA)74CT-P13 3 mg/kg+MTX302*/248†760.9*/73.3†Referent42.3†Referent20.2†Referent
IFX 3 mg/kg+MTX304*/251†58.6*/69.7†NS40.6†NS17.9†NS
C. Targeted synthetic DMARDvan Vollenhoven 2012 (ORAL STANDARD)76Placebo106628.3ReferentReferentReferent
Tofacitinib 5 mg twice daily19651.5<0.001≤0.05≤0.05
Tofacitinib 10 mg twice daily19652.6<0.001≤0.05≤0.05
ADA 40 mg every 2 weeks19947.2<0.001≤0.05≤0.05
  • All RCTs are in MTX incomplete responders.

  • *Intention-to-treat population.

  • †Per protocol populations.

  • ABT, abatacept; ADA, adalimumab; IFX, infliximab; MTX, methotrexate; NS, non-significant; RTX, rituximab; TCZ, tocilizumab.